NEW YORK--(BUSINESS WIRE)--Aug. 10, 2009--
Nycomed and Forest Laboratories Holdings Limited, a wholly owned
subsidiary of Forest Laboratories, Inc. (NYSE: FRX), today announced
that they have entered into a definitive collaboration and distribution
agreement for Daxas® (roflumilast) in the United States. Daxas®
is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor
that has been developed by Nycomed for the treatment of COPD (chronic
obstructive pulmonary disease) and for which Nycomed submitted an NDA
with the FDA in July.
Under the terms of the agreement, Forest will make an upfront payment to
Nycomed of $100 million and will pay future, undisclosed milestone
payments. In addition, Nycomed will receive royalties based on Daxas
sales. Forest will assume responsibility for the US regulatory approval
and commercialization of Daxas in the United States and the companies
will collaborate on future development programs.
Håkan Björklund, Chief Executive Officer of Nycomed, said: “We have
received considerable interest in the marketing rights to Daxas and we
believe Forest Laboratories is the best possible partner for Nycomed in
the US. Forest Laboratories has a significant US sales force, an
increasing focus on respiratory products and an unrivalled track record
of partnering with European companies to build hugely successful
franchises. We believe their absolute commitment to Daxas will help to
bring this innovative new therapy to as many patients in the United
Sates as possible who suffer from COPD, a disease which is predicted to
become the third-leading cause of death worldwide by 2030.”
Howard Solomon, Chairman and Chief Executive Officer of Forest, said,
"We are pleased to have entered into this collaboration with Nycomed.
Nycomed has demonstrated great dedication in bringing Daxas to its
current NDA stage of development and we are looking forward to working
with such a talented and committed group as we consider ways to further
develop and expand the use of Daxas. Daxas represents the first in a new
class of agents to treat COPD and would be the first oral agent to be
approved for this debilitating disease. If approved, Daxas will give
physicians and patients a much needed new treatment option in a unique
oral dosage form that can augment the existing armamentarium of inhaled
therapies.” In addition Mr. Solomon commented that “oglemilast, our
phase II PDE4 inhibitor licensed from Glenmark remains in active
development for both COPD and asthma and represents a potentially
complementary opportunity.”
In a recently completed Phase III pivotal program consisting of two
studies in a total of over 3,000 patients with COPD, Daxas demonstrated
statistically significant improvements compared to placebo on the
co-primary endpoints of moderate to severe exacerbations and
pre-bronchodilator FEV1 over a 12 month treatment period in both
studies. Daxas also demonstrated a statistically significant improvement
compared to placebo on the primary endpoint, pre-bronchodilator FEV1, in
two supportive studies over a six month period when used in conjunction
with commonly used long-acting bronchodilators.
About Daxas®
Daxas is an orally administered phosphodiesterase 4 (PDE4) enzyme
inhibitor, targeting cells and mediators in the body believed to be
important in the COPD disease process. Daxas is expected to act on an
underlying mechanism of COPD and related inflammatory diseases. If
approved, Daxas, a once-a-day tablet, will be the first drug in its
class. It will also be the first oral anti-inflammatory treatment for
COPD patients. Current treatment for COPD patients includes the use of
inhaled bronchodilators and inhaled corticosteroids.
Nycomed’s most recent and very extensive program for Daxas included two
international Phase III, 12-month trials, HERMES and AURA, which
included over 3,000 patients. The primary aim of both studies was to
investigate the effect of Daxas on exacerbation rates and pulmonary
function (pre-bronchodilator FEV1) in predominantly severe and very
severe COPD patients. Daxas (500 μg roflumilast) was administered orally
once daily for up to 52 weeks. The randomized, double-blind,
placebo-controlled studies were conducted in a number of territories,
including the US, Europe, Canada, Australia, Russia, India and South
Africa. Both HERMES and AURA met their primary endpoint objectives.
Two additional supportive double-blind, placebo-controlled Phase III
studies, EOS and HELIOS, evaluated the efficacy of Daxas in more than
1,500 patients, the majority with moderate COPD, when used concomitantly
with standard bronchodilator treatments for COPD, i.e., tiotropium or
salmeterol. The primary endpoint was the mean change from baseline in
pre-bronchodilator FEV1. Both EOS and HELIOS demonstrated a
statistically significant improvement in the primary endpoint with Daxas
given in combination with a long acting bronchodilator compared to the
same bronchodilator given alone.
Full data from all four studies are to be published in a leading
peer-reviewed journal later this year and will be presented at the
annual European Respiratory Society (ERS) Congress in Vienna, Austria,
in September.
Two earlier double-blind placebo-controlled Phase III studies in COPD
with Daxas demonstrated statistically significant effects on FEV1
compared to placebo treatment and showed a positive trend with respect
to exacerbation improvement which was not statistically significantly
different than placebo.
Daxas is protected by a composition of matter patent through January 27,
2015 and is eligible for patent term extension which should provide an
additional five years of exclusivity beyond the life of the patent.
About COPD
COPD remains a significant area of unmet medical need. It is a
progressive and irreversible lung disease resulting in difficulty in
breathing. The disease is characterized by severe episodes of worsening,
called exacerbations. According to World Health Organization (WHO)
estimates, 80 million people have moderate to severe COPD worldwide.
More than 3 million people died of COPD in 2005, which corresponds to 5%
of all deaths globally. The WHO predicts that total deaths from COPD
could increase by more than 30% in the next 10 years unless urgent
action is taken to reduce the underlying risk factors, especially
smoking.
(see http://www.who.int/respiratory/copd/burden/en/index.html)
About Nycomed
Nycomed is a privately owned global pharmaceutical company with a
differentiated portfolio focused on branded medicines in
gastroenterology, respiratory and inflammatory diseases, pain,
osteoporosis and tissue management. An extensive range of OTC products
completes the portfolio.
Its R&D is structured around partnerships and in-licensing is a
cornerstone of the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are
available in more than 100 countries. It has strong platforms in Europe
and in fast-growing markets such as Russia/CIS and Latin America. While
the US and Japan are commercialized through best-in-class partners,
Nycomed plans to further strengthen its own position in key Asian
markets.
Headquartered in Zurich, Switzerland, the company generated total sales
of €3.4 billion in 2008 and an adjusted EBITDA of €1.2 billion.
For more information visit www.nycomed.com.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a
wide range of therapeutic areas. The company is headquartered in New
York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a
number of risks and uncertainties, including the difficulty of
predicting FDA approvals, the acceptance and demand for new
pharmaceutical products, the impact of competitive products and pricing,
the timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Report on Form
10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.
Source: Forest Laboratories, Inc.
Forest Laboratories, Inc.
Frank J. Murdolo, +1-212-224-6714
Vice
President - Investor Relations,
Frank.Murdolo@frx.com